MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-11-28 for BARD UROLASE FIBER 3500SL manufactured by Trimedyne, Incorporated.
[16818910]
It was reported that during a bhp procedure, the fiber tip burned up after lasing at 60 watts for 60 seconds and detached from the fiber shaft and remained in pt's bladder. Grasping forceps were used through the previously placed cytoscope to retreive the detached tip. No further complications were reported. Invalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-1994-00012 |
| MDR Report Key | 31799 |
| Date Received | 1994-11-28 |
| Date of Report | 1994-11-15 |
| Date of Event | 1994-11-10 |
| Date Facility Aware | 1994-11-15 |
| Report Date | 1994-11-15 |
| Date Reported to FDA | 1994-11-15 |
| Date Reported to Mfgr | 1994-11-15 |
| Date Added to Maude | 1996-03-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD UROLASE FIBER |
| Generic Name | UROLASE FIBER |
| Product Code | FKW |
| Date Received | 1994-11-28 |
| Catalog Number | 3500SL |
| Lot Number | 03FET002 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 32939 |
| Manufacturer | TRIMEDYNE, INCORPORATED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-11-28 |